13103-EN Rev K
Safety and Compliance 13
Safety Compliance
Complies with FDA performance standards for laser products except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007.
CE-marked devices comply with all requirements of the European Medical Device Directive
MDD 93/42/EEC.
Illuminating Probe Specifications
The following information on the illumination capabilities of this device is provided in accordance
with ISO 15752, Section 6.2.
Feature
Specification
Effective Aperture
0.5 mm
Numerical Aperture
0.5 - 0.8
Light Guide Materials
PMMA or Silica
Illumination Testing
The following information on the illumination capabilities of this device is provided in accordance
with ISO 15752, Section 4.4.2.
Measurement of the aphakic weighted irradiance of an illuminating EndoProbe may be made under
sterile conditions. Follow the instructions provided by the manufacturer of your EndoIlluminator
light source. Drape the EndoProbe handpiece with a sterile sleeve, or grip the EndoProbe with a
sterile clamp, forceps, or gloves. Do not compromise the sterile tip.
